Module 5 Presentations

Module 5: Regulatory Control of Clinical Operations 17 th – 19 th July 2024 Date: Friday 19 th July 2024

Time

Activity

Speaker

08.45 – 08.50

Introduction

Chairperson Eva Kopecna Acino International Mohamed Oubihi Yakumed (remote)

08.50 – 09.50

Lecture 9: Regulatory requirements for clinical trials - Japan Legislation requirements Clinical Trial Notifications

Japanese Regulatory Authorities Consultations with the Authorities Clinical Trials in Japan & GCP

09.50 – 10.30

Refreshment Break

10.30 – 11.30

Lecture 10: Legal aspects of clinical trials Product Information and Informed Consent Data Protection. Enforcement and Sanctions Liability. Clinical Study Contracts Lecture 11: Regulatory requirements for clinical trials – US and Canada Legislation requirements CTA and IND applications & maintenance Ethics Committee GCP & Enforcement

Adela Williams Arnold & Porter (remote)

11.30 – 12.30

Sarah Roberts Icon (remote)

12.30 – 13.30

Lunch

13.30 – 13.45

Introduction to Case study 2: GCP and Clinical Development Programme

Eva Kopecna Acino International

13.45 – 14.45

Case Study 2: GCP and Clinical Development Programme

14.45 – 15.15

Feedback from Case Study 2